Deliver consulting projects to support implementation of laboratory enterprise system (e.g., LES, LIMS) in the Life Sciences clients.
Deliver consulting projects to support introduction, upgrade and maintenance of laboratory equipment with computerised system in the Life Sciences clients.
Draft CQV and CSV deliverables such as URS, risk assessment, audit trail assessment, ERES assessment, IOPQ protocols, specifications and RTM.
Execute CQ and CSV activities.
Support equipment integration with other system such as network, manufacturing system and enterprise system.
Support system configuration and CS activities such as backup and restore, access management, periodic review, etc.
Draft, revise and review SOPs, forms and related operational and maintenance documents.
Requirements:
Hold Bachelor's degree in Life Sciences, Engineering or related field.
Have worked at least 2 years in pharmaceutical, medical device or related environment.
Fresh graduates with internship in pharmaceutical or medical device industry and some relevant experience may apply for a Junior role.
Must have experience in configuring systems like LIMS (e.g., Labware), LES (e.g., Biovia LES), ELN, CDS (e.g., Empower, OpenLab), etc.
Understand computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISPE GAMP5).
Preferably with experience qualifying laboratory equipment with computerised system in pharmaceutical / medical device settings.
Preferably with experience in change, incident and problem management.
Preferably with technical knowledge of Windows OS, security system and backup system.
Why Join ORKA:
Work that Matters: Support clients bringing innovative and life saving solutions to the population.
Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.
